Prosthetic heart valve device and associated systems and methods

ABSTRACT

A method for treating a native valve of a human heart having a native annulus and native leaflets includes positioning a capsule of a delivery device proximate a native heart valve. The method further includes partially deploying a prosthetic heart valve device from the capsule such that an inflow region of a valve support and an inflow region of a fixation structure are radially expanded. A portion of the prosthetic heart valve device remains coupled to the delivery device while a gap exists between a downstream end of a prosthetic valve disposed within the valve support and a distal terminus of the capsule such that fluid can flow through the prosthetic valve with the prosthetic heart valve device partially deployed. The method may further include recapturing the prosthetic heart valve device within the capsule.

This application is a divisional of U.S. patent application Ser. No.15/490,047, filed Apr. 18, 2017. The entire contents of application Ser.No. 15/490,047 is incorporated herein by reference.

TECHNICAL FIELD

The present technology relates generally to prosthetic heart valvedevices. Several embodiments of the present technology are well suitedfor percutaneous repair and/or replacement of native mitral valves.

BACKGROUND

Heart valves can be affected by several conditions. For example, mitralvalves can be affected by mitral valve regurgitation, mitral valveprolapse and mitral valve stenosis. Mitral valve regurgitation isabnormal leaking of blood from the left ventricle into the left atriumcaused by a disorder of the heart in which the leaflets of the mitralvalve fail to coapt into apposition at peak contraction pressures. Themitral valve leaflets may not coapt sufficiently because heart diseasesoften cause dilation of the heart muscle, which in turn enlarges thenative mitral valve annulus to the extent that the leaflets do not coaptduring systole. Abnormal backflow can also occur when the papillarymuscles are functionally compromised due to ischemia or otherconditions. More specifically, as the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulgeabnormally up in to the left atrium. This can cause irregular behaviorof the mitral valve and lead to mitral valve regurgitation. The leafletsmay prolapse and fail to coapt because the tendons connecting thepapillary muscles to the inferior side of the mitral valve leaflets(chordae tendineae) may tear or stretch. Mitral valve stenosis is anarrowing of the mitral valve orifice that impedes filling of the leftventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/orvasodilators to reduce the amount of blood flowing back into the leftatrium. Surgical approaches (open and intravascular) for either therepair or replacement of the valve have also been used to treat mitralvalve regurgitation. For example, typical repair techniques involvecinching or resecting portions of the dilated annulus. Cinching, forexample, includes implanting annular or peri-annular rings that aregenerally secured to the annulus or surrounding tissue. Other repairprocedures suture or clip the valve leaflets into partial appositionwith one another.

Alternatively, more invasive procedures replace the entire valve itselfby implanting mechanical valves or biological tissue into the heart inplace of the native mitral valve. These invasive proceduresconventionally require large open thoracotomies and are thus verypainful, have significant morbidity, and require long recovery periods.Moreover, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may cause additional problems for the patient. Repair proceduresalso require a highly skilled cardiac surgeon because poorly orinaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have beenimplemented in recent years. Examples of pre-assembled, percutaneousprosthetic valves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame and a tri-leaflet bioprostheticvalve attached to the expandable frame. The aortic valve issubstantially symmetric, circular, and has a muscular annulus. Theexpandable frames in aortic applications have a symmetric, circularshape at the aortic valve annulus to match the native anatomy, but alsobecause tri-leaflet prosthetic valves require circular symmetry forproper coaptation of the prosthetic leaflets. Thus, aortic valve anatomylends itself to an expandable frame housing a replacement valve sincethe aortic valve anatomy is substantially uniform, symmetric, and fairlymuscular. Other heart valve anatomies, however, are not uniform,symmetric or sufficiently muscular, and thus transvascular aortic valvereplacement devises may not be well suited for other types of heartvalves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale, and instead emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. For ease of reference, throughout thisdisclosure identical reference numbers and/or letters are used toidentify similar or analogous components or features, but the use of thesame reference number does not imply that the parts should be construedto be identical. Indeed, in many examples described herein, identicallynumbered components refer to different embodiments that are distinct instructure and/or function. The headings provided herein are forconvenience only.

FIG. 1 is a schematic, cross-sectional illustration of the heart showingan antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 2 is a schematic, cross-sectional illustration of the heart showingaccess through the inter-atrial septum (IAS) maintained by the placementof a guide catheter over a guidewire in accordance with variousembodiments of the present technology.

FIGS. 3 and 4 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 5 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 6A is a cross-sectional side view and FIG. 6B is a top viewschematically illustrating a prosthetic heart valve device in accordancewith an embodiment of the present technology.

FIGS. 7A and 7B are cross-sectional side views schematicallyillustrating aspects of delivering a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 8 is a top isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 9A is a side view of the prosthetic heart valve device of FIG. 8 ,and FIG. 9B is a detailed view of a portion of the prosthetic heartvalve device shown in FIG. 9A.

FIG. 10 is a bottom isometric view of the prosthetic heart valve deviceof FIG. 9A.

FIG. 11 is a side view and FIG. 12A is a bottom isometric view of aprosthetic heart valve device in accordance with an embodiment of thepresent technology.

FIG. 12B is an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the present technology, and FIG.12C is a detailed view of a portion of the heart valve device shown inFIG. 12B.

FIG. 13 is a side view and FIG. 14 is a bottom isometric view of theprosthetic heart valve device of FIGS. 11 and 12 at a partially deployedstate with respect to a delivery device.

FIG. 15 is a bottom isometric view of a valve support for use withprosthetic heart valve devices in accordance with the presenttechnology.

FIGS. 16 and 17 are side and bottom isometric views, respectively, of aprosthetic heart valve attached to the valve support of FIG. 15 .

FIGS. 18 and 19 are side views schematically showing valve supports inaccordance with additional embodiments of the present technology.

FIG. 20 is a schematic view of an arm unit of an anchoring member foruse with prosthetic heart valve devices in accordance with the presenttechnology.

FIG. 21 is a schematic view of an arm unit of an anchoring member foruse with prosthetic heart valve devices in accordance with the presenttechnology.

FIG. 22 is a schematic view of a portion of the arm units of FIGS. 20and 21 in accordance with the present technology.

FIG. 23 is a schematic view of an arm unit of an anchoring member foruse with prosthetic heart valve devices in accordance with the presenttechnology.

FIGS. 24A and 24B are schematic views showing arms having differenceconfigurations of eyelets for coupling a sealing member to an anchoringmember in accordance with the present technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-19 . Although many of the embodimentsare described below with respect to prosthetic valve devices, systems,and methods for percutaneous replacement of a native mitral valve, otherapplications and other embodiments in addition to those described hereinare within the scope of the technology. Additionally, several otherembodiments of the technology can have different configurations,components, or procedures than those described herein. A person ofordinary skill in the art, therefore, will accordingly understand thatthe technology can have other embodiments with additional elements, orthe technology can have other embodiments without several of thefeatures shown and described below with reference to FIGS. 1-19 .

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a location where blood flows into the device (e.g., inflowregion), and distal can refer to a downstream position or a locationwhere blood flows out of the device (e.g., outflow region).

Overview

Several embodiments of the present technology are directed to mitralvalve replacement devices that address the unique challenges ofpercutaneously replacing native mitral valves and are well-suited to berecaptured in a percutaneous delivery device after being partiallydeployed for repositioning or removing the device. Compared to replacingaortic valves, percutaneous mitral valve replacement faces uniqueanatomical obstacles that render percutaneous mitral valve replacementsignificantly more challenging than aortic valve replacement. First,unlike relatively symmetric and uniform aortic valves, the mitral valveannulus has a non-circular D-shape or kidney-like shape, with anon-planar, saddle-like geometry often lacking symmetry. The complex andhighly variable anatomy of mitral valves makes it difficult to design amitral valve prosthesis that conforms well to the native mitral annulusof specific patients. As a result, the prosthesis may not fit well withthe native leaflets and/or annulus, which can leave gaps that allowsbackflow of blood to occur. For example, placement of a cylindricalvalve prosthesis in a native mitral valve may leave gaps in commissuralregions of the native valve through which perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for use in mitral valves. First, many ofthese devices require a direct, structural connection between thestent-like structure that contacts the annulus and/or leaflets and theprosthetic valve. In several devices, the stent posts which support theprosthetic valve also contact the annulus or other surrounding tissue.These types of devices directly transfer the forces exerted by thetissue and blood as the heart contracts to the valve support and theprosthetic leaflets, which in turn distorts the valve support from itsdesired cylindrical shape. This is a concern because most cardiacreplacement devices use tri-leaflet valves, which require asubstantially symmetric, cylindrical support around the prosthetic valvefor proper opening and closing of the three leaflets over years of life.As a result, when these devices are subject to movement and forces fromthe annulus and other surrounding tissues, the prostheses may becompressed and/or distorted causing the prosthetic leaflets tomalfunction. Moreover, a diseased mitral annulus is much larger than anyavailable prosthetic aortic valve. As the size of the valve increases,the forces on the valve leaflets increase dramatically, so simplyincreasing the size of an aortic prosthesis to the size of a dilatedmitral valve annulus would require dramatically thicker, tallerleaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over thecourse of each heartbeat, the mitral valve annulus lacks a significantamount of radial support from surrounding tissue. Compared to aorticvalves, which are completely surrounded by fibro-elastic tissue thatprovides sufficient support for anchoring a prosthetic valve, mitralvalves are bound by muscular tissue on the outer wall only. The innerwall of the mitral valve anatomy is bound by a thin vessel wallseparating the mitral valve annulus from the inferior portion of theaortic outflow tract. As a result, significant radial forces on themitral annulus, such as those imparted by an expanding stent prostheses,could lead to collapse of the inferior portion of the aortic tract.Moreover, larger prostheses exert more force and expand to largerdimensions, which exacerbates this problem for mitral valve replacementapplications.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. Unlike aortic valves, mitralvalves have a maze of cordage under the leaflets in the left ventriclethat restrict the movement and position of a deployment catheter and thereplacement device during implantation. As a result, deploying,positioning and anchoring a valve replacement device on the ventricularside of the native mitral valve annulus is complicated.

Embodiments of the present technology provide systems, methods andapparatus to treat heart valves of the body, such as the mitral valve,that address the challenges associated with the anatomy of the mitralvalve and provide for repositioning and removal of a partially deployeddevice. The apparatus and methods enable a percutaneous approach using acatheter delivered intravascularly through a vein or artery into theheart, or through a cannula inserted through the heart wall. Forexample, the apparatus and methods are particularly well-suited fortrans-septal approaches, but can also be trans-apical, trans-atrial, anddirect aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. Additionally, the embodiments of the devices andmethods as described herein can be combined with many known surgeriesand procedures, such as known methods of accessing the valves of theheart (e.g., the mitral valve or triscuspid valve) with antegrade orretrograde approaches, and combinations thereof.

The devices and methods described herein provide a valve replacementdevice that can be recaptured in a delivery device after being onlypartially deployed to reposition and/or remove the device. The devicealso has the flexibility to adapt and conform to the variably-shapednative mitral valve anatomy while mechanically isolating the prostheticvalve from the anchoring portion of the device. Several embodiments ofthe device effectively absorb the distorting forces applied by thenative anatomy. The device has the structural strength and integritynecessary to withstand the dynamic conditions of the heart over time,thus permanently anchoring a replacement valve. The devices and methodsfurther deliver such a device in a less-invasive manner, providing apatient with a new, permanent replacement valve but also with alower-risk procedure and a faster recovery.

Access to the Mitral Valve

To better understand the structure and operation of valve replacementdevices in accordance with the present technology, it is helpful tofirst understand approaches for implanting the devices. The mitral valveor other type of atrioventricular valve can be accessed through thepatient's vasculature in a percutaneous manner. By percutaneous it ismeant that a location of the vasculature remote from the heart isaccessed through the skin, typically using a surgical cut down procedureor a minimally invasive procedure, such as using needle access through,for example, the Seldinger technique. The ability to percutaneouslyaccess the remote vasculature is well known and described in the patentand medical literature. Depending on the point of vascular access,access to the mitral valve may be antegrade and may rely on entry intothe left atrium by crossing the inter-atrial septum (e.g., atrans-septal approach). Alternatively, access to the mitral valve can beretrograde where the left ventricle is entered through the aortic valve.Access to the mitral valve may also be achieved using a cannula via atrans-apical approach. Depending on the approach, the interventionaltools and supporting catheter(s) may be advanced to the heartintravascularly and positioned adjacent the target cardiac valve in avariety of manners, as described herein.

FIG. 1 illustrates a stage of a trans-septal approach for implanting avalve replacement device. In a trans-septal approach, access is via theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the inter-atrial septum IAS, and into the left atriumLA above the mitral valve MV. As shown in FIG. 1 , a catheter 1 having aneedle 2 moves from the inferior vena cava IVC into the right atrium RA.Once the catheter 1 reaches the anterior side of the inter-atrial septumIAS, the needle 2 advances so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. At this point, a guidewire replaces the needle 2 and the catheter 1is withdrawn.

FIG. 2 illustrates a subsequent stage of a trans-septal approach inwhich guidewire 6 and guide catheter 4 pass through the inter-atrialseptum IAS. The guide catheter 4 provides access to the mitral valve forimplanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter passes through this puncture or incision directlyinto the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, antegradeapproaches will usually enable more precise and effective centering andstabilization of the guide catheter and/or prosthetic valve device. Theantegrade approach may also reduce the risk of damaging the chordaetendineae or other subvalvular structures with a catheter or otherinterventional tool. Additionally, the antegrade approach may decreaserisks associated with crossing the aortic valve as in retrogradeapproaches. This can be particularly relevant to patients withprosthetic aortic valves, which cannot be crossed at all or withoutsubstantial risk of damage.

FIGS. 3 and 4 show examples of a retrograde approaches to access themitral valve. Access to the mitral valve MV may be achieved from theaortic arch AA, across the aortic valve AV, and into the left ventricleLV below the mitral valve MV. The aortic arch AA may be accessed througha conventional femoral artery access route or through more directapproaches via the brachial artery, axillary artery, radial artery, orcarotid artery. Such access may be achieved with the use of a guidewire6. Once in place, a guide catheter 4 may be tracked over the guidewire6. Alternatively, a surgical approach may be taken through an incisionin the chest, preferably intercostally without removing ribs, andplacing a guide catheter through a puncture in the aorta itself. Theguide catheter 4 affords subsequent access to permit placement of theprosthetic valve device, as described in more detail herein. Retrogradeapproaches advantageously do not need a trans-septal puncture.Cardiologists also more commonly use retrograde approaches, and thusretrograde approaches are more familiar.

FIG. 5 shows a trans-apical approach via a trans-apical puncture. Inthis approach, access to the heart is via a thoracic incision, which canbe a conventional open thoracotomy or sternotomy, or a smallerintercostal or sub-xyphoid incision or puncture. An access cannula isthen placed through a puncture in the wall of the left ventricle at ornear the apex of the heart. The catheters and prosthetic devices of theinvention may then be introduced into the left ventricle through thisaccess cannula. The trans-apical approach provides a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalapproach does not require training in interventional cardiology toperform the catheterizations required in other percutaneous approaches.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods

Embodiments of the present technology can treat one or more of thevalves of the heart, and in particular several embodimentsadvantageously treat the mitral valve. The prosthetic valve devices ofthe present technology can also be suitable for replacement of othervalves (e.g., a bicuspid or tricuspid valve) in the heart of thepatient. Examples of prosthetic heart valve devices, system componentsand associated methods in accordance with embodiments of the presenttechnology are described in this section with reference to FIGS. 6A-19 .Specific elements, substructures, advantages, uses, and/or otherfeatures of the embodiments described with reference to FIGS. 6A-19 canbe suitably interchanged, substituted or otherwise configured with oneanother. Furthermore, suitable elements of the embodiments describedwith reference to FIGS. 6A-19 can be used as stand-alone and/orself-contained devices.

FIG. 6A is a side cross-sectional view and FIG. 6B is a top plan view ofa prosthetic heart valve device (“device”) 100 in accordance with anembodiment of the present technology. The device 100 includes a valvesupport 110, an anchoring member 120 attached to the valve support 110,and a prosthetic valve assembly 150 within the valve support 110.Referring to FIG. 6A, the valve support 110 has an inflow region 112 andan outflow region 114. The prosthetic valve assembly 150 is arrangedwithin the valve support 110 to allow blood to flow from the inflowregion 112 through the outflow region 114 (arrows BF), but prevent bloodfrom flowing in a direction from the outflow region 114 through theinflow region 112.

In the embodiment shown in FIG. 6A, the anchoring member 120 includes abase 122 attached to the outflow region 114 of the valve support 110 anda plurality of arms 124 projecting laterally outward from the base 122.The anchoring member 120 also includes a fixation structure 130extending from the arms 124. The fixation structure 130 can include afirst portion 132 and a second portion 134. The first portion 132 of thefixation structure 130, for example, can be an upstream region of thefixation structure 130 that, in a deployed configuration as shown inFIG. 6A, is spaced laterally outward apart from the inflow region 112 ofthe valve support 110 by a gap G. The second portion 134 of the fixationstructure 130 can be a downstream-most portion of the fixation structure130. The fixation structure 130 can be a cylindrical ring (e.g.,straight cylinder or conical), and the outer surface of the fixationstructure 130 can define an annular engagement surface configured topress outwardly against the native annulus. The fixation structure 130can further include a plurality of fixation elements 136 that projectradially outward and are inclined toward an upstream direction. Thefixation elements 136, for example, can be barbs, hooks, or otherelements that are inclined only in the upstream direction (e.g., adirection extending away from the downstream portion of the device 100).

Referring still to FIG. 6A, the anchoring member 120 has a smooth bend140 between the arms 124 and the fixation structure 130. For example,the second portion 134 of the fixation structure 130 extends from thearms 124 at the smooth bend 140. The arms 124 and the fixation structure130 can be formed integrally from a continuous strut or support elementsuch that the smooth bend 140 is a bent portion of the continuous strut.In other embodiments, the smooth bend 140 can be a separate componentwith respect to either the arms 124 or the fixation structure 130. Forexample, the smooth bend 140 can be attached to the arms 124 and/or thefixation structure 130 using a weld, adhesive or other technique thatforms a smooth connection. The smooth bend 140 is configured such thatthe device 100 can be recaptured in a capsule or other container afterthe device 100 has been at least partially deployed.

The device 100 can further include a first sealing member 162 on thevalve support 110 and a second sealing member 164 on the anchoringmember 120. The first and second sealing members 162, 164 can be madefrom a flexible material, such as Dacron® or another type of polymericmaterial. The first sealing member 162 can cover the interior and/orexterior surfaces of the valve support 110. In the embodimentillustrated in FIG. 6A, the first sealing member 162 is attached to theinterior surface of the valve support 110, and the prosthetic valveassembly 150 is attached to the first sealing member 162 and commissureportions of the valve support 110. The second sealing member 164 isattached to the inner surface of the anchoring member 120. As a result,the outer annular engagement surface of the fixation structure 130 isnot covered by the second sealing member 164 so that the outer annularengagement surface of the fixation structure 130 directly contacts thetissue of the native annulus.

The device 100 can further include an extension member 170. Theextension member 170 can be an extension of the second sealing member164, or it can be a separate component attached to the second sealingmember 164 and/or the first portion 132 of the fixation structure 130.The extension member 170 can be a flexible member that, in a deployedstate as shown in FIG. 6A, flexes relative to the first portion 132 ofthe fixation structure 130. In operation, the extension member 170provides tactile feedback or a visual indicator (e.g., onechocardiographic or fluoroscopic imaging systems) to guide the device100 during implantation such that the device is located at a desiredelevation and centered relative to the native annulus. As describedbelow, the extension member 170 can include a support member, such as ametal wire or other structure, that can be visualized duringimplantation. For example, the support member can be a radiopaque wire.

FIGS. 7A and 7B are cross-sectional views illustrating an example of theoperation of the smooth bend 140 between the arms 124 and the fixationstructure 130 in the recapturing the device 100 after partialdeployment. FIG. 7A schematically shows the device 100 loaded into acapsule 700 of a delivery system in a delivery state, and FIG. 7Bschematically shows the device 100 in a partially deployed state.Referring to FIG. 7A, the capsule 700 has a housing 702, a support 704,and a top 706. In the delivery state shown in FIG. 7A, the device 100 isin a low-profile configuration suitable for delivery through a catheteror cannula to a target implant site at a native heart valve.

Referring to FIG. 7B, the housing 702 of the capsule 700 has been moveddistally such that the extension member 170, fixation structure 130 anda portion of the arms 124 have been released from the housing 702 in apartially deployed state. This is useful for locating the fixationstructure 130 at the proper elevation relative to the native valveannulus A such that the fixation structure 130 expands radially outwardand contacts the inner surface of the native annulus A. However, thedevice 100 may need to be repositioned and/or removed from the patientafter being partially deployed. To do this, the housing 702 is retracted(arrow R) back toward the fixation structure 130. As the housing 702slides along the arms 124, the smooth bend 140 between the arms 124 andthe fixation structure 130 allows the edge 708 of the housing 702 toslide over the smooth bend 140 and thereby recapture the fixationstructure 130 and the extension member 170 within the housing 702. Thedevice 100 can then be removed from the patient or repositioned forredeployment at a better location relative to the native annulus A.Further aspects of prosthetic heart valve devices in accordance with thepresent technology and their interaction with corresponding deliverydevices are described below with reference to FIGS. 8-19 .

FIG. 8 is a top isometric view of an example of the device 100. In thisembodiment, the valve support 110 defines a first frame (e.g., an innerframe) and fixation structure 130 of the anchoring member 120 defines asecond frame (e.g., an outer frame) that each include a plurality ofstructural elements. The fixation structure 130, more specifically,includes structural elements 137 arranged in diamond-shaped cells 138that together form at least a substantially cylindrical ring when freelyand fully expanded as shown in FIG. 8 . The structural elements 137 canbe struts or other structural features formed from metal, polymers, orother suitable materials that can self-expand or be expanded by aballoon or other type of mechanical expander.

Several embodiments of the fixation structure 130 can be a generallycylindrical fixation ring having an outwardly facing engagement surface.For example, in the embodiment shown in FIG. 8 , the outer surfaces ofthe structural elements 137 define an annular engagement surfaceconfigured to press outwardly against the native annulus in the deployedstate. In a fully expanded state without any restrictions, the fixationstructure 130 is at least substantially parallel to the valve support110. However, the fixation structure 130 can flex inwardly (arrow I) inthe deployed state when it presses radially outwardly against the innersurface of the native annulus of a heart valve.

The embodiment of the device 100 shown in FIG. 8 includes the firstsealing member 162 lining the interior surface of the valve support 110,and the second sealing member 164 along the inner surface of thefixation structure 130. The extension member 170 has a flexible web 172(e.g., a fabric) and a support member 174 (e.g., metal or polymericstrands) attached to the flexible web 172. The flexible web 172 canextend from the second sealing member 164 without a metal-to-metalconnection between the fixation structure 130 and the support member174. For example, the extension member 170 can be a continuation of thematerial of the second sealing member 164. Several embodiments of theextension member 170 are thus a floppy structure that can readily flexwith respect to the fixation structure 130. The support member 174 canhave a variety of configurations and be made from a variety ofmaterials, such as a double-serpentine structure made from Nitinol.

FIG. 9A is a side view, FIG. 9B is a detailed view of a portion of FIG.9A, and FIG. 10 is a bottom isometric view of the device 100 shown inFIG. 8 . Referring to FIG. 9A, the arms 124 extend radially outward fromthe base portion 122 at an angle α selected to position the fixationstructure 130 radially outward from the valve support 110 (FIG. 8 ) by adesired distance in a deployed state. The angle α is also selected toallow the edge 708 of the housing 702 (FIG. 7B) to slide from the baseportion 122 toward the fixation structure 130 during recapturing. Inmany embodiments, the angle α is 15°-75°, or more specifically 15°-60°,or still more specifically 30°-45°. The arms 124 and the structuralelements 137 of the fixation structure 130 can be formed from the samestruts (i.e., formed integrally with each other) such that the smoothbend 140 is a continuous, smooth transition from the arms 124 to thestructural elements 137. This is expected to enable the edge 708 of thehousing 702 to more readily slide over the smooth bend 140 in a mannerthat allows the fixation structure 130 to be recaptured in the housing702 of the capsule 700 (FIG. 7B). Additionally, by integrally formingthe arms 124 and the structural elements 137 with each other, it reducesthe potential of breaking the device 100 at a junction between the arms124 and the structural elements 137 compared to a configuration in whichthe arms 124 and structural elements 137 are separate components andwelded or otherwise fastened to each other. FIGS. 9A and 9B also showthat the device 100 can further include chevron-support struts at theoutflow region that extend between the arms 124 at the base 122 of theanchoring member 120. The chevron-supports at the base 122 do notnecessarily have a “smooth bend,” such as the smooth bend 140 at thetransition from the arms 124 to the downstream-most portion of thefixation structure 130. As such, so long as the chevron-supports andother elements of the device 100 project toward the inflow region toallow recapture, certain portions of the device 100, and the anchoringmember 120 in particular, need not have such a smooth bend.

Referring to FIGS. 9B and 10 , the arms 124 are arranged in V-shaped armunits 125 that each have a pair of arms 124 extending from a bifurcation127 at the base portion 122. In this embodiment, the individual arms 124in each V-shaped arm unit 125 are separated from each other along theirentire length from where they are connected to the base portion 122through the smooth bend 140 (FIG. 9A) to the structural elements 137 ofthe fixation structure 130. The individual arms 124 are thus able toreadily flex as the edge 708 of the housing 702 (FIG. 7B) slides alongthe arms 124 during recapturing. This is expected to reduce thelikelihood that the edge 708 of the housing 702 will catch on the arms124 and prevent the device 100 from being recaptured in the housing 702.

In one embodiment, the arms 124 have a first length from the base 122 tothe smooth bend 140, and the structural elements 137 of the fixationstructure 130 at each side of a cell 138 (FIG. 8 ) have a second length.The second length of the structural elements 137 along each side of acell 138 is less than the first length of the arms 124. The fixationstructure 130 is accordingly less flexible than the arms 124. As aresult, the fixation structure 130 is able to press outwardly againstthe native annulus with sufficient force to secure the device 100 to thenative annulus, while the arms 124 are sufficiently flexible to foldinwardly when the device is recaptured in a delivery device.

In the embodiment illustrated in FIGS. 8-10 , the arms 124 and thestructural elements 137 are configured such that each arm 124 and thetwo structural elements 137 extending from each arm 124 formed aY-shaped portion 142 (FIG. 10 ) of the anchoring member 120.Additionally, the right-hand structural element 137 of each Y-shapedportion 142 is coupled directly to a left-hand structural element 137 ofan immediately adjacent Y-shaped portion 142. The Y-shaped portions 142and the smooth bends 140 are expected to further enhance the ability toslide the housing 702 along the arms 124 and the fixation structure 130during recapturing.

FIG. 11 is a side view and FIG. 12A is a bottom isometric view of aprosthetic heart valve device (“device”) 200 in accordance with anotherembodiment of the present technology. The device 200 is shown withoutthe extension member 170 (FIGS. 8-10 ), but the device 200 can furtherinclude the extension member 170 described above. The base 122 of thedevice 200 shown in FIG. 12A further includes only a single row ofchevron-supports 216 as opposed to the dual-rows of chevron-supports atthe base 122 of the device 100 shown in FIG. 10 . The device 200 furtherincludes extended connectors 210 projecting from the base 122 of theanchoring member 120. Alternatively, the extended connectors 210 canextend from the valve support 110 (FIGS. 6A-10 ) in addition to or inlieu of extending from the base 122 of the anchoring member 120. Theextended connectors 210 can include a first strut 212 a attached to oneportion of the base 122 and a second strut 212 b attached to anotherportion of the base 122. The first and second struts 212 a-b areconfigured to form a V-shaped structure in which they extend toward eachother in a downstream direction and are connected to each other at thebottom of the V-shaped structure. The V-shaped structure of the firstand second struts 212 a-b causes the extension connector 210 to elongatewhen the device 200 is in a low-profile configuration within the capsule700 (FIG. 7A) during delivery or partial deployment. When the device 200is fully released from the capsule 700 (FIG. 7A) the extensionconnectors 210 foreshorten to avoid interfering with blood flow alongthe left ventricular outflow tract.

The extended connectors 210 further include an attachment element 214configured to releasably engage a delivery device. The attachmentelement 214 can be a T-bar or other element that prevents the device 200from being released from the capsule 700 (FIG. 7A) of a delivery deviceuntil desired. For example, a T-bar type attachment element 214 canprevent the device 200 from moving axially during deployment or partialdeployment until the housing 702 (FIG. 7A) moves distally beyond theattachment elements 214 such that the outflow region of the valvesupport 110 and the base 122 of the anchoring member 120 can fullyexpand upon full deployment.

FIG. 12B is an isometric view of a prosthetic heart valve device 200 a(“device 200 a”) in accordance with another embodiment of the presenttechnology, and FIG. 12C is a detailed view of an arm unit of the device200 a. The device 200 a is substantially similar to the device 200 shownin FIG. 12A, but the device 200 a includes a plurality of Y-shaped armunits 224 instead of V-shaped arm units. Referring to FIG. 12C, the armunits 224 have a trunk 226 and two arms 228 extending from the trunk 226at a bifurcation 227. The trunk 226 of each Y-shaped arm unit 224extends from a single row of chevron-supports 216 at the base 122 of theanchoring member 120, and the trunks 226 have a length such that thebifurcations 227 are located a distance apart from the base 122. Thearms 228 of the Y-shaped arm units 224 can be slightly shorter than thearms 124 of the V-shaped arm units 125 described above with respect toFIG. 9B, but the overall lengths of the Y-shaped and V-shaped arm units224 and 125 can be about the same. The Y-shaped arm units 224 reduce theamount of metal in the region of the chevron-supports 216 compared tothe V-shaped arm units 125, which reduces the material at the base 122of the anchoring member 120 so that the device 200 a can be crimped to asmaller diameter for delivery. Moreover, the Y-shaped arm units 224 arealso sufficiently flexible so that the device 200 a can be resheathed ina capsule of a delivery device. FIG. 13 is a side view and FIG. 14 is abottom isometric view of the device 200 in a partially deployed state inwhich the device 200 is still capable of being recaptured in the housing702 of the delivery device 700. Referring to FIG. 13 , the device 200 ispartially deployed with the fixation structure 130 substantiallyexpanded but the attachment elements 214 (FIG. 11 ) still retainedwithin the capsule 700. This is useful for determining the accuracy ofthe position of the device 200 and allowing blood to flow through thefunctioning replacement valve during implantation while retaining theability to recapture the device 200 in case it needs to be repositionedor removed from the patient. In this state of partial deployment, theelongated first and second struts 212 a-b of the extended connectors 210space the base 122 of the anchoring member 120 and the outflow region ofthe valve support 110 (FIG. 6A) apart from the edge 708 of the capsule702 by a gap G.

Referring to FIG. 14 , the gap G enables blood to flow through theprosthetic valve assembly 150 while the device 200 is only partiallydeployed. As a result, the device 200 can be partially deployed todetermine (a) whether the device 200 is positioned correctly withrespect to the native heart valve anatomy and (b) whether proper bloodflow passes through the prosthetic valve assembly 150 while the device200 is still retained by the delivery system 700. As such, the device200 can be recaptured if it is not in the desired location and/or if theprosthetic valve is not functioning properly. This additionalfunctionality is expected to significantly enhance the ability toproperly position the device 200 and assess, in vivo, whether the device200 will operate as intended, while retaining the ability to repositionthe device 200 for redeployment or remove the device 200 from thepatient.

FIG. 15 is a bottom isometric view of a valve support 300 in accordancewith an embodiment of the present technology. The valve support 300 canbe an embodiment of the valve support 110 described above with respectto FIGS. 6A-14 . The valve support 300 has an outflow region 302, aninflow region 304, a first row 310 of first hexagonal cells 312 at theoutflow region 302, and a second row 320 of second hexagonal cells 322at the inflow region 304. The valve support shown in FIG. 15 is invertedcompared to the valve support 100 shown in FIGS. 6A-14 for purposes ofillustration such that the blood flows through the valve support 300 inthe direction of arrow BF. In mitral valve applications, the valvesupport 300 would be positioned within the anchoring member 120 (FIG.6A) such that the inflow region 304 would correspond to orientation ofthe inflow region 112 in FIG. 6A and the outflow region 302 wouldcorrespond to the orientation of the outflow region 114 in FIG. 6A.

Each of the first hexagonal cells 312 includes a pair of firstlongitudinal supports 314, a downstream apex 315, and an upstream apex316. Each of the second hexagonal cells 322 can include a pair of secondlongitudinal supports 324, a downstream apex 325, and an upstream apex326. The first and second rows 310 and 320 of the first and secondhexagonal cells 312 and 322 are directly adjacent to each other. In theillustrated embodiment, the first longitudinal supports 314 extenddirectly from the downstream apexes 325 of the second hexagonal cells322, and the second longitudinal supports 324 extend directly from theupstream apexes 316 of the first hexagonal cells 312. As a result, thefirst hexagonal cells 312 are offset circumferentially from the secondhexagonal cells 322 around the circumference of the valve support 300 byhalf of the cell width.

In the embodiment illustrated in FIG. 15 , the valve support 300includes a plurality of first struts 331 at the outflow region 302, aplurality of second struts 332 at the inflow region 304, and a pluralityof third struts 333. Each of the first struts 331 extends from adownstream end of the first longitudinal supports 314, and pairs of thefirst struts 331 are connected together to form first downstreamV-struts defining the downstream apexes 315 of the first hexagonal cells312. In a related sense, each of the second struts 332 extends from anupstream end of the second longitudinal supports 324, and pairs of thesecond struts 332 are connected together to form second upstreamV-struts defining the upstream apexes 326 of the second hexagonal cells322. Each of the third struts 333 has a downstream end connected to anupstream end of the first longitudinal supports 314, and each of thethird struts 333 has an upstream end connected to a downstream end ofone of the second longitudinal supports 324. The downstream ends of thethird struts 333 accordingly define a second downstream V-strutarrangement that forms the downstream apexes 325 of the second hexagonalcells 322, and the upstream ends of the third struts 333 define a firstupstream V-strut arrangement that forms the upstream apexes 316 of thefirst hexagonal cells 312. The third struts 333, therefore, define boththe first upstream V-struts of the first hexagonal cells 312 and thesecond downstream V-struts of the second hexagonal cells 322.

The first longitudinal supports 314 can include a plurality of holes 336through which sutures can pass to attach a prosthetic valve assemblyand/or a sealing member. In the embodiment illustrated in FIG. 15 , onlythe first longitudinal supports 314 have holes 336. However, in otherembodiments the second longitudinal supports 324 can also include holeseither in addition to or in lieu of the holes 336 in the firstlongitudinal supports 314.

FIG. 16 is a side view and FIG. 17 is a bottom isometric view of thevalve support 300 with a first sealing member 162 attached to the valvesupport 300 and a prosthetic valve 150 within the valve support 300. Thefirst sealing member 162 can be attached to the valve support 300 by aplurality of sutures 360 coupled to the first longitudinal supports 314and the second longitudinal supports 324. At least some of the sutures360 coupled to the first longitudinal supports 314 pass through theholes 336 to further secure the first sealing member 162 to the valvesupport 300. Sutures 360 can also pass through the holes 336 if holes336 are included in addition to or in lieu of the holes 336 of the firstlongitudinal supports 314.

Referring to FIG. 17 , the prosthetic valve 150 can be attached to thefirst sealing member 162 and/or the first longitudinal supports 314 ofthe valve support 300. For example, the commissure portions of theprosthetic valve 150 can be aligned with the first longitudinal supports314, and the sutures 360 can pass through both the commissure portionsof the prosthetic valve 150 and the first sealing member 162 where thecommissure portions of the prosthetic valve 150 are aligned with a firstlongitudinal support 314. The inflow portion of the prosthetic valve 150can be sewn to the first sealing member 162.

The valve support 300 illustrated in FIGS. 15-17 is expected to be wellsuited for use with the device 100 and 200 and described above withreference to FIGS. 8-10 and 11-14 , respectively. More specifically, thefirst struts 331 cooperate with the base of the anchoring member 122.The first struts 331, for example, elongate when the valve support 300is not fully expanded compared to when the valve support is fullyexpanded. In addition to the elongation of the struts, the position ofthe prosthetic valve 150 within the valve support 300 allows the outflowportion of the prosthetic valve 150 to be spaced further apart from thecapsule 700 in a partially deployed state so that the prosthetic valve150 can at least partially function in the partially deployed state.Alternatively, if attached to the device 200, the extended connectors210 (FIGS. 11-14 ) of the device 200 serve to further separate theoutflow portion of the prosthetic valve 150 from the capsule 700 (FIGS.13-14 ) when the device 200 is in a partially deployed state, allowingfor partial function of the prosthetic valve 150. Upon full deployment,the first struts 331 foreshorten. Therefore, the valve support 300 isexpected to enhance the ability to assess whether the prosthetic valve150 is fully operational in a partially deployed state. This additionalfunctionality is expected to significantly enhance the ability toassess, in vivo, whether the device 100 and 200 will operate asintended, while retaining the ability to reposition the device 100 and200 for redeployment or remove the device 100 and 200 from the patient.

FIGS. 18 and 19 are schematic side views of valve supports 400 and 500,respectively, in accordance with embodiments of the present technology.The valve support 400 includes a first row 410 of first of hexagonalcells 412 and a second row 420 of second hexagonal cells 422. The valve400 can further include a first row 430 of diamond-shaped cellsextending from the first hexagonal cells 412 and a second row 440 ofdiamond-shaped cells extending from the second hexagonal cells 422. Theadditional diamond-shaped cells elongate in the low-profile state, andthus they can further space the prosthetic valve 150 (shownschematically) apart from the capsule of the delivery device, enhancingthe ability to assess, in vivo, whether the device will operate asintended while retaining the ability to reposition or remove the devicefrom the patient. Referring to FIG. 19 , the valve support 500 includesa first row 510 of first hexagonal cells 512 at an outflow region 502and a second row 520 of second hexagonal cells 522 at an inflow region504. The valve support 500 is shaped such that an intermediate region506 has a smaller cross-sectional area than that of the outflow region502 and/or the inflow region 504. As such, the first row 510 of firsthexagonal cells 512 flares outwardly in the downstream direction and thesecond row 520 of second hexagonal cells 522 flares outwardly in theupstream direction. The flared outflow and inflow regions 502 and 504are expected to improve blood flow through the valve support 500.Additionally, the flared outflow and inflow regions 502 and 504 reducethe length of the valve support compared to a straight cylindricaldesign, which reduces the amount that the valve support 500 extends intothe left ventricle.

FIG. 20 is a schematic view showing a portion of an anchoring member 120in accordance with an embodiment of the present technology. In thisembodiment, the anchoring member 120 includes the fixation structure 130and V-shaped arm units 620 (only a single arm unit shown). Each V-shapedarm unit 620 includes a pair of arms 622 extending from the base 122 tothe fixation structure 130 (only a portion shown), and each arm 622includes a first portion 624 having a first flexibility and a secondportion 626 with a second flexibility less than the first flexibility.The first portion 624 of the arms 622 are selectively flexible at thebase 122 of the anchoring member 120, while the second portion 626 ofthe arms 622 have sufficient stiffness to push the fixation structure130 radially outwardly for engaging the native annulus. In theillustrated embodiment, the first portion 624 of the arms 622 are aserpentine member (e.g., an according connector), and the second portion626 of the arms 622 are straighter than the first portion 624. Forexample the second portion 626 of the arms 622 can curve radiallyoutward along an arc (e.g. a single arc) as opposed to the serpentine orthe zig-zag configuration of the first portion 624.

FIG. 21 is a schematic view showing a portion of another anchoringmember 120 in accordance with an embodiment of the present technologyincluding Y-shaped arm units 720 (only a single arm unit 720 shown).Each Y-shaped arm unit 720 has a trunk 724 and arms 726 extending fromthe trunk 724. The trunk 724 has a first flexibility, and the arms 726have a second flexibility less than the first flexibility. The trunk724, for example, is a strut having a serpentine configuration (e.g., anaccordion connector), and the arms 726 can be curved struts extendingradially outward from the trunk 724 in an expanded configuration.

FIG. 22 schematically illustrates the operation of the arm units 620 and720 shown in FIGS. 20 and 21 . In operation, the native annulus (notshown) exerts a compressive annulus force F_(A) against the fixationstructure 130 while the systolic pressure creates a force F_(P). Theadditional flexibility of the first portion 624 or the trunk 724 allowsthe arm units 620 and 720 to preferentially flex near the outflow end ofthe valve support 110 to allow the fixation structure 130 to be deformedby the native annulus while mitigating the commissure forces Fc exertedagainst the valve support 110 at the base 122. Notably, the secondportion 626 of the arms 622 and the arms 726 are sufficiently stiff toprovide the desired radially outward force against the native annulusfor securing the prosthetic heart valve device at the native heartvalve.

FIG. 23 illustrates an arm 800 supporting a fixation structure 130 inaccordance with another embodiment of the present technology. The arm800 can include a first portion 820 configured to be coupled to theoutflow region of a valve support and a second portion 822 extendingfrom the first portion 820 to the fixation structure 130. The firstportion 820 of the arm 800 can correspond to the first portion 624 ofthe arms 622 of the V-shaped arm unit 620 or the trunk 724 of theY-shaped arm unit 720. The first portion 820 of the arm 800 can furtherinclude a plurality of outward recesses 824 (e.g., notches) that enablethe first portion 822 preferentially flex outward (arrow O). The arm 800is expected to perform substantially similarly to the arms 622 and theY-shaped arm unit 720 described above with reference to FIGS. 20-22 .

FIGS. 24A and 24B are schematic views showing arms 124 having differenceconfigurations of eyelets 900 for coupling the second sealing member 164(FIGS. 6A and 6B) to the anchoring member 120. Referring to FIG. 24A,the eyelets 900 are on the outside of the arms 124. Referring to FIG.24B, the eyelets are on the inside of the arms 124. In both embodiments,sutures 902 pass through the eyelets to attach the second sealing member164 to the inside of the anchoring member 120. The embodiment shown inFIG. 24B is particularly well-suited for resheathing the prostheticheart valve devices because the eyelets are shape-set to extend inwardlyto eliminate or otherwise limit protrusions relative to the outersurface of the arms 124 that could inhibit the capsule from sliding overthe arms 124 during resheathing.

EXAMPLES

Several aspects of the present technology described above are embodiedin the following examples.

-   1. A prosthetic heart valve device for treating a native valve of a    human heart having a native annulus and native leaflets, comprising:    -   a valve support having an inflow region and an outflow region;    -   a prosthetic valve assembly within the valve support; and    -   an anchoring member having a base attached to the outflow region        of the valve support, a plurality of arms projecting laterally        outward from the base and inclined in an upstream direction in a        deployed state, and a fixation structure extending upstream from        the arms, the fixation structure having a plurality of struts        that define an annular engagement surface configured to press        outwardly against the native annulus and a plurality of fixation        elements projecting from the struts, wherein a downstream-most        portion of the fixation structure extends from the arms at a        smooth bend and fixation elements at the downstream-most portion        of the fixation structure extend in an upstream direction.-   2. The prosthetic heart valve device of example 1 wherein the arms    are spaced apart from each other throughout their length.-   3. The prosthetic heart valve device of any of examples 1-2 wherein    the struts of the fixation structure are arranged in cells having    sides, and the arms have a first length and each side of the cells    has a second length less than the first length.-   4. The prosthetic heart valve device of any of examples 1-3 wherein    each arm and the struts of the fixation structure extending from    each arm form a Y-shaped portion of the anchoring member, and a    right-hand strut of each Y-shaped portion is coupled directly to a    left-hand strut of an immediately adjacent Y-shaped portion.-   5. The prosthetic heart valve device of any of examples 1-4, further    comprising connector extensions projecting from a downstream end of    the valve support and/or the base, and wherein each connector    extension has first and second struts forming a V-shaped structure    extending downstream from the valve support and/or the base, and a    connector projecting downstream from the V-shaped structure, wherein    the connector is configured to be releasably held by a delivery    device.-   6. The prosthetic heart valve device of any of examples 1-5 wherein    all of the fixation elements projecting from the fixation structure    extend in an upstream direction.-   7. The prosthetic heart valve device of any of examples 1-6 wherein    the valve support comprises:    -   a first row of first hexagonal cells at the outflow region of        the valve support, and the first hexagonal cells having first        longitudinal supports;    -   a second row of second hexagonal cells at the inflow region of        the valve support, the second hexagonal cells having second        longitudinal supports, wherein the first and second hexagonal        cells are directly adjacent to each other such that the first        longitudinal supports extend directly from downstream apexes of        the second hexagonal cells and the second longitudinal supports        extend directly from upstream apexes of the first hexagonal        cells; and    -   wherein the prosthetic valve assembly is attached to at least        one of the first longitudinal supports and/or at least one of        the second longitudinal supports.-   8. The prosthetic heart valve device of example 7 wherein the valve    support further comprises a first row of diamond-shaped cells at a    downstream end of the first row of hexagonal cells and a second row    of diamond-shaped cells at an upstream end of the second row of    hexagonal cells.-   9. The prosthetic heart valve device of example 7 wherein the first    row of hexagonal cells flares outward in the downstream direction    and the second row of hexagonal cells flares outward in the upstream    direction.-   10. The prosthetic heart valve device of example 7, further    comprising connector extensions projecting from a downstream end of    the valve support and/or the base, and wherein each connector    extension has first and second struts forming a V-shaped structure    extending downstream from the valve support and/or the base, and a    connector projecting downstream from the V-shaped structure, wherein    the connector is configured to be releasably held by a delivery    device.-   11. The prosthetic heart valve device of any of examples 1-10    wherein the valve support comprises:    -   a first row of first hexagonal cells at the outflow region of        the valve support, wherein the first hexagonal cells have first        longitudinal supports, first upstream V-struts extending        upstream from the first longitudinal supports, and first        downstream V-struts extending downstream from the first        longitudinal supports;    -   a second row of second hexagonal cells at the inflow region of        the valve support, wherein the second hexagonal cells have        second longitudinal supports, second upstream V-struts extending        upstream from the second longitudinal supports, and second        downstream V-struts extending downstream from the second        longitudinal supports; and    -   wherein the first upstream V-struts of the first hexagonal cells        and the second downstream inverted V-struts of the second        hexagonal cells are the same struts.-   12. A prosthetic heart valve device for treating a native valve of a    human heart having a native annulus and native leaflets, comprising:    -   an annular inner support frame having an inflow region and an        outflow region;    -   a prosthetic valve assembly within the inner support frame; and    -   an anchoring member having a base attached to the outflow region        of the inner support frame, a plurality of arms projecting        laterally outward from the base at an angle inclined in an        upstream direction, and an outer fixation frame extending        upstream from the arms, the outer fixation frame having a        plurality of struts that define an annular engagement surface        spaced radially outward from the inflow region of the inner        support frame in the deployed state, wherein the arms and the        struts are configured to be partially deployed from a capsule        and then at least substantially recaptured within the capsule by        moving at least one of the capsule and/or the device relative to        the other such the arms and struts slide into the capsule.-   13. The prosthetic heart valve device of example 12 wherein the arms    are spaced apart from each other throughout their length.-   14. The prosthetic heart valve device of any of examples 12-13    wherein the struts of the outer fixation frame are arranged in cells    having sides, and the arms have a first length and each side of the    cells has a second length less than the first length.-   15. The prosthetic heart valve device of any of examples 12-14    wherein each arm and the struts of the outer fixation frame    extending from each arm form a Y-shaped portion of the anchoring    member, and a right-hand strut of each Y-shaped portion is coupled    directly to a left-hand strut of an immediately adjacent Y-shaped    portion.-   16. The prosthetic heart valve device of any of examples 12-15,    further comprising connector extensions projecting from a downstream    end of the inner annular support frame and/or the base, and wherein    each connector extension has first and second struts forming a    V-shaped structure extending downstream from the inner annular    support frame and/or the base, and a connector projecting downstream    from the V-shaped structure, wherein the connector is configured to    be releasably held by a delivery device.-   17. The prosthetic heart valve device of any of examples 12-16,    further comprising fixation elements projecting from the outer    fixation frame, and wherein all of the fixation elements project    from the outer fixation frame extend in an upstream direction.-   18. The prosthetic heart valve device of any of examples 12-17    wherein the inner annular support frame comprises:    -   a first row of first hexagonal cells at the outflow region of        the inner annular support frame, and the first hexagonal cells        having first longitudinal supports;    -   a second row of second hexagonal cells at the inflow region of        the inner annular support frame, the second hexagonal cells        having second longitudinal supports, wherein the first and        second hexagonal cells are directly adjacent to each other such        that the first longitudinal supports extend directly from        downstream apexes of the second hexagonal cells and the second        longitudinal supports extend directly from upstream apexes of        the first hexagonal cells; and    -   wherein the prosthetic valve assembly is attached to at least        one of the first longitudinal supports and/or at least one of        the second longitudinal supports.-   19. The prosthetic heart valve device of example 18 wherein the    inner annular support frame further comprises a first row of    diamond-shaped cells at a downstream end of the first row of    hexagonal cells and a second row of diamond-shaped cells at an    upstream end of the second row of hexagonal cells.-   20. The prosthetic heart valve device of example 18 wherein the    first row of hexagonal cells flares outward in the downstream    direction and the second row of hexagonal cells flares outward in    the upstream direction.-   21. The prosthetic heart valve device of example 18, further    comprising connector extensions projecting from a downstream end of    the inner annular support frame and/or the base, and wherein each    connector extension has first and second struts forming a V-shaped    structure extending downstream from the inner annular support frame    and/or the base, and a connector projecting downstream from the    V-shaped structure, wherein the connector is configured to be    releasably held by a delivery device.-   22. The prosthetic heart valve device of any of examples 1-21    wherein the arms are arranged in pairs defining V-shaped arm units.-   23. The prosthetic heart valve device of example 22 wherein the    V-shaped arm units have a pair of arm, and each arm has a first    portion having a first flexibility and a second portion having a    second flexibility less than the first flexibility.-   24. The prosthetic heart valve device of example 23 wherein the    first portion has a serpentine configuration.-   25. the prosthetic heart valve device of example 23 wherein the    first portion has outwardly open notches.-   26. The prosthetic heart valve device of any of examples 1, 3-12 and    14-21 wherein the arms are arranged in Y-shaped arm units having a    trunk and a pair of arms extending from the trunk.-   27. The prosthetic heart valve device of examples 26 wherein the    trunk has a first flexibility and the arms have a second flexibility    less than the first flexibility.-   28. The prosthetic heart valve device of example 27 wherein the    trunk has a serpentine configuration.-   29. The prosthetic heart valve device of example 27 wherein the    trunk has a plurality of outwardly open notches.-   30. A method of deploying a prosthetic heart valve device for    treating a native heart valve, comprising:    -   partially deploying a prosthetic heart valve device from a        capsule of a delivery device such that an inflow region of a        valve support and an inflow region of a fixation structure are        expanded radially outward relative to the capsule with the        inflow region of the fixation structure being spaced radially        outward of the valve support, wherein an outflow region of the        valve support and/or the fixation structure remains within the        capsule, and wherein a gap exists between a downstream end of a        prosthetic valve within the valve support and a distal terminus        of the capsule such that fluid can flow through the valve while        the outflow region is within the capsule; and    -   recapturing the prosthetic heart valve device within the        capsule.-   31. The method of example 30 wherein the native heart valve is a    native mitral valve.-   32. The method of example 30 wherein the native heart valve is a    native aortic valve.-   33. A valve support for a prosthetic heart valve, comprising:    -   a first row of first hexagonal cells at an outflow region of the        valve support, wherein the first hexagonal cells have first        longitudinal supports, first and second upstream struts        extending upstream from the first longitudinal supports, and        first and second downstream struts extending downstream from the        first longitudinal supports;    -   a second row of second hexagonal cells at an inflow region of        the valve support, wherein the second hexagonal cells have        second longitudinal supports, first and second upstream struts        extending upstream from the second longitudinal supports, and        first and second downstream struts extending downstream from the        second longitudinal supports; and    -   wherein the first and second upstream struts of the first        hexagonal cells and the first and second downstream struts of        the second hexagonal cells are the same struts.-   34. The valve support of example 33 wherein the first and second    longitudinal supports have a first width and the first and second    upstream struts and the first and second downstream struts have a    second width less than the first width.-   35. The valve support of any of examples 33-34 wherein:    -   the first and second hexagonal cells are directly adjacent to        each other such that the first longitudinal supports extend        directly from downstream apexes of the second hexagonal cells        and the second longitudinal supports extend directly from        upstream apexes of the first hexagonal cells; and    -   wherein the prosthetic valve assembly is attached to at least        one of the first longitudinal supports and/or at least one of        the second longitudinal supports.-   36. The prosthetic heart valve device of any of examples 33-35    wherein the valve support further comprises a first row of    diamond-shaped cells at a downstream end of the first row of    hexagonal cells and a second row of diamond-shaped cells at an    upstream end of the second row of hexagonal cells.-   37. The prosthetic heart valve device of any of examples 33-36    wherein the first row of hexagonal cells flares outward in the    downstream direction and the second row of hexagonal cells flares    outward in the upstream direction.-   38. The prosthetic heart valve device of any of examples 33-37,    further comprising connector extensions projecting from a downstream    end of the first hexagonal cells, and wherein each connector    extension has first and second struts forming a V-shaped structure    extending downstream from the first hexagonal cells, and a connector    projecting downstream from the V-shaped structure, wherein the    connector is configured to be releasably held by a delivery device.

From the foregoing, it will be appreciated that specific embodiments ofthe invention have been described herein for purposes of illustration,but that various modifications may be made without deviating from thescope of the invention. For example, several individual components canbe interchange with each other in the different embodiments.Accordingly, the invention is not limited except as by the appendedclaims.

I claim:
 1. A method comprising: positioning a capsule of a deliverydevice proximate a native heart valve; partially deploying a prostheticheart valve device from the capsule of the delivery device such that aninflow region of a valve support and an inflow region of a fixationstructure are expanded radially outward relative to the capsule with theinflow region of the fixation structure being spaced radially outward ofthe valve support, wherein a portion of the prosthetic heart valvedevice remains disposed within the capsule of the delivery device whilea gap exists between a downstream end of a prosthetic valve at anoutflow region of the valve support and a distal terminus of the capsulesuch that fluid can flow through the prosthetic valve while the portionof the prosthetic heart valve device remains within the capsule of thedelivery device, wherein the prosthetic valve is within the valvesupport; and recapturing the prosthetic heart valve device within thecapsule.
 2. The method of claim 1, wherein the native heart valve is anative mitral valve.
 3. The method of claim 1, wherein the native heartvalve is a native aortic valve.
 4. The method of claim 1, wherein theprosthetic heart valve device further comprises arms coupled to theoutflow region of the valve support and the fixation structure extendsfrom the arms along a smooth bend, and wherein recapturing theprosthetic heart valve device within the capsule comprises holding adownstream end of the prosthetic heart valve device while sliding thecapsule over the arms and the smooth bend.
 5. The method of claim 1,wherein the gap is formed by connector extensions extending in adownstream direction with respect to the outflow region of the valvesupport.
 6. The method of claim 1, wherein the prosthetic heart valvedevice comprises: a plurality of arms configured to project laterallyoutward from the outflow region of the valve support and be inclined inan upstream direction in a deployed state, wherein the fixationstructure is configured to extend upstream from the plurality of arms.7. The method of claim 6, wherein the fixation structure comprises aplurality of struts that define an annular engagement surface configuredto press outwardly against the native heart valve and a plurality offixation elements projecting from the struts.
 8. The method of claim 7,wherein a downstream-most portion of the fixation structure isconfigured to extend from the plurality of arms at a smooth bend, andwherein all of the fixation elements project from the fixation structurein an upstream direction.
 9. The method of claim 8, wherein theplurality of arms, the plurality of struts, and the plurality offixation elements are configured to be at least partially deployed fromthe capsule and then at least substantially recaptured within thecapsule.
 10. A method comprising: positioning a capsule of a deliverydevice proximate a native heart valve; partially deploying a prostheticheart valve device from the capsule of the delivery device such that aninflow region of a valve support and an inflow region of a fixationstructure are expanded radially outward relative to the capsule with theinflow region of the fixation structure being spaced radially outward ofthe valve support, wherein a portion of the prosthetic heart valvedevice remains coupled to the delivery device while a gap exists betweena downstream end of a prosthetic valve at an outflow region of the valvesupport and a distal terminus of the capsule such that fluid can flowthrough the prosthetic valve while the prosthetic heart valve deviceremains coupled to the delivery device, wherein the prosthetic valve iswithin the valve support; and recapturing the prosthetic heart valvedevice within the capsule, wherein the prosthetic heart valve devicecomprises a plurality of arms configured to project laterally outwardfrom the outflow region of the valve support and be inclined in anupstream direction in a deployed state, wherein the fixation structureis configured to extend upstream from the plurality of arms, wherein thefixation structure comprises a plurality of struts that define anannular engagement surface configured to press outwardly against thenative heart valve and a plurality of fixation elements projecting fromthe struts, and wherein each arm of the plurality of arms and the strutsof the fixation structure extending from each arm form a Y-shapedportion, and a right-hand strut of each Y-shaped portion is coupleddirectly to a left-hand strut of an immediately adjacent Y-shapedportion.
 11. A method comprising: positioning a capsule of a deliverydevice proximate a native heart valve; partially deploying a prostheticheart valve device from the capsule of the delivery device such that aninflow region of a valve support and an inflow region of a fixationstructure are expanded radially outward relative to the capsule with theinflow region of the fixation structure being spaced radially outward ofthe valve support, wherein a portion of the prosthetic heart valvedevice remains coupled to the delivery device while a gap exists betweena downstream end of a prosthetic valve at an outflow region of the valvesupport and a distal terminus of the capsule such that fluid can flowthrough the prosthetic valve while the prosthetic heart valve deviceremains coupled to the delivery device, wherein the prosthetic valve iswithin the valve support; and recapturing the prosthetic heart valvedevice within the capsule, wherein the valve support comprises: a firstrow of first hexagonal cells at the outflow region of the valve support,and the first hexagonal cells having first longitudinal supports; asecond row of second hexagonal cells at the inflow region of the valvesupport, the second hexagonal cells having second longitudinal supports,wherein the first and second hexagonal cells are directly adjacent toeach other such that the first longitudinal supports extend directlyfrom downstream apexes of the second hexagonal cells and the secondlongitudinal supports extend directly from upstream apexes of the firsthexagonal cells; and wherein the prosthetic valve assembly is attachedto at least one of the first longitudinal supports and/or at least oneof the second longitudinal supports.
 12. The method of claim 11, whereinthe valve support further comprises a first row of diamond-shaped cellsat a downstream end of the first row of hexagonal cells and a second rowof diamond-shaped cells at an upstream end of the second row ofhexagonal cells.
 13. The method of claim 11, wherein the first row ofhexagonal cells flares outward in a downstream direction and the secondrow of hexagonal cells flares outward in an upstream direction.
 14. Themethod of claim 11, further comprising connector extensions projectingfrom a downstream end of the valve support, and wherein each connectorextension has first and second struts forming a V-shaped structureextending downstream from the valve support, and a connector projectingdownstream from the V-shaped structure, wherein the connector isconfigured to be releasably held by the delivery device.